Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone [ Time Frame: From baseline to surgery, up to 42 days ]

The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.

Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF [ Time Frame: Up to 12 months ]

Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.

The change in the endpoints (p16 methylation and expression of p16, COX-2, VEGF, EGFR, IL6, p53 and Bcl-xL) will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.

Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF [ Time Frame: Up to 12 months ]

Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.

Survival and relapse-free survival functions will be estimated using the product-limit (Kaplan-Meier) method, with appropriate confidence intervals, for the entire sample and for subsets defined by demographic and baseline clinical variables. In addition, proportional hazards (Cox) regression will be used to assess the potential of biomarker response to treatment as a predictor of survival and relapse-free survival. These analyses are strictly exploratory and hypothesis-generating.

Relapse-free survival [ Time Frame: Up to 24 months ]

Survival and relapse-free survival functions will be estimated using the product-limit (Kaplan-Meier) method, with appropriate confidence intervals, for the entire sample and for subsets defined by demographic and baseline clinical variables. In addition, proportional hazards (Cox) regression will be used to assess the potential of biomarker response to treatment as a predictor of survival and relapse-free survival. These analyses are strictly exploratory and hypothesis-generating.

Incidence of observed toxicities [ Time Frame: Up to 30 days after surgery ]

Adverse events observed in the pre-operative and immediate (30 day) post-operative period will be tabulated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade and description, assessed relationship to treatment, and demographic and baseline clinical variables. The analyses will be descriptive and no hypothesis tests are planned.

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery

Official Title ICMJE

A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma

Brief Summary

This phase II clinical trial studies how well soy isoflavones work in preventing head and neck cancer in patients with stage I-IV head and neck cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones may prevent head and neck cancer recurrence.

Pregnancy or lactation; patients of child bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of soy administration

A medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment or comply with administration of study drug

Patients residing in prison

Any patient with a history of breast or ovarian cancer

Allergy to soy products

Sex/Gender

Sexes Eligible for Study:

All

Ages

19 Years to 79 Years (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects